Evekeo

Amphetamine Sulfate

What is the most important information I should know about amphetamine?

Amphetamine may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Amphetamine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems --chest pain, feeling light-headed or short of breath; signs of psychosis --paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems --unexplained wounds on your fingers or toes.

What is amphetamine?

Amphetamine is a central nervous system stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Amphetamine is used to treat attention deficit hyperactivity disorder (ADHD).

The Evekeo brand of amphetamine is used to treat ADHD and also narcolepsy. Evekeo is sometimes used to treat obesity in people who have not lost weight with diets or other treatments.

Amphetamine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking amphetamine?

You should not use amphetamine if you are allergic to any stimulant medicine, or if you have:

moderate to severe high blood pressure;

overactive thyroid;

severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or

a history of drug or alcohol addiction.

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Some medicines can interact with amphetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

heart problems or a congenital heart defect;

high blood pressure; or

a family history of heart disease or sudden death.

To make sure amphetamine is safe for you, tell your doctor if you or anyone in your family has ever had:

Taking this medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Amphetamine is not approved for use by anyone younger than 6 years old.

How should I take amphetamine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Amphetamine may be habit-forming. Never share amphetamine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

If your doctor changes your brand, strength, or type of stimulant medicine, your dosage needs may change. Use only the brand of this medicine your doctor has prescribed.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

To take the orally disintegrating tablet (Adzenys XR-ODT):

Remove a tablet from its blister pack only when you are ready to take the tablet. Use dry hands and take care not to damage a tablet while pushing it out of the blister.

Place the tablet in your mouth and allow it to dissolve, without chewing or swallowing it whole. Sip liquid if needed to help swallow the dissolved tablet.

While using this medicine, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Keep track of your medicine. Amphetamine is a drug of abuse and you should be aware if anyone is using it improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.

What should I avoid while taking amphetamine?

Avoid drinking alcohol while you are taking this medicine.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine. These can make your body absorb less of the medicine.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

What are the possible side effects of amphetamine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Amphetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

stomach pain, nausea, vomiting, diarrhea, constipation;

loss of appetite, weight loss;

mood changes, feeling restless or nervous, sleep problems (insomnia);

dry mouth, unusual or unpleasant taste in the mouth;

runny nose, nosebleeds;

increased heart rate;

headache, dizziness;

itching; or

impotence, sexual problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect amphetamine?

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs amphetamine, and may increase side effects.

Many drugs can affect amphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about amphetamine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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